SUMC-EC-002: Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer
Study Details
Study Description
Brief Summary
This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SMART boost Radiotherapy with simultaneous modulated accelerated boost |
Radiation: Radiotherapy with simultaneous modulated accelerated boost
Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases
Other Names:
Drug: PF
Chemotherapy: Cisplatin and 5fluorouracil
|
| Active Comparator: Standard dose RT Standard dose radiotherapy |
Radiation: Standard dose radiotherapy
Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease
Drug: PF
Chemotherapy: Cisplatin and 5fluorouracil
|
Outcome Measures
Primary Outcome Measures
- Overall survival [2 years]
Secondary Outcome Measures
- Local-regional control [2 years]
- Distant metastasis-free survival [2 years]
- Disease-free survival [2 years after randomization]
- Acute and late toxicities using CTCAE v4.0 [2 years]
The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs.
- Quality of life as assessed with FACT-E [2 years]
FACT-E score
- Quality of life as measured with EQ-5D [2 years]
The score of EQ-5D questionnaire
- Biomarkers [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologic proof of primary squamous cell carcinoma of the esophagus.
-
Primary disease at cervical, upper or middle thoracic esophagus
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T1-4, N any, M0 (except supraclavicular lymph node).
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Age≥18 & ≤75.
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ECOG score 0-2.
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Platelets ≥ 150,000, Hgb ≥ 10 gm%, ANC ≥ 1500, serum creatinine ≤ 1.5 mg/dl.
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Adequate liver function.
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Patients with prior malignancy are eligible if disease-free ≥ 5 years.
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No prior chest radiotherapy, systemic chemotherapy or major esophageal surgery.
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Signed study-specific informed consent form prior to study entry.
Exclusion Criteria:
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Patients with tracheo-esophageal fistula.
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Patients with invasion into mucosa of trachea or major bronchi.
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Patients with uncontrolled serious medical or mental illnesses.
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Prior RT that would result in overlap of planned RT fields.
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Pregnancy or women of childbearing potential and men who are sexually active
-
Women who are breastfeeding a baby.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Hospital, Shantou University Medical College | Shantou | Guangdong | China | 515031 |
Sponsors and Collaborators
- Chuangzhen Chen
Investigators
- Principal Investigator: Chuangzhen Chen, MD, Cancer Hospital, Shantou University Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SUMC-EC-002